Evaluation of the Effects of Heating or Massaging or Vibrating at the Vicinity of the Insulin Delivery Site

This study is not yet open for participant recruitment.

Verified by Insuline Medical Ltd., October 2008

Sponsored by:	Insuline Medical Ltd.
Information provided by:	Insuline Medical Ltd.
ClinicalTrials.gov Identifier:	NCT00767741

Purpose

The aim of this study is to test the pharmacodynamics of insulin analogs and their dependence on external and physiological alterations. We plan to compare the pharmacodynamics of insulin analog delivery in regular conditions and in the presence of increased perfusion of the delivery site, achieved by way of local warming and movement

Condition	Intervention
Diabetes	Device: with heat and massage

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Crossover Assignment, Efficacy Study
Official Title:	Evaluation of the Effects of Heating or Massaging or Vibrating at the Vicinity of the Insulin Delivery Site

Further study details as provided by Insuline Medical Ltd.:

Primary Outcome Measures:

Insulin blood level with and with out the intervention [ Time Frame: at the end of every daily study ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	November 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
with treatment: Experimental	Device: with heat and massage For the with intervention group a treatment to the injection site is applied after each insulin bolus injection.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Participant age between 18- 65 years old
Type I or Type II diabetes
HbA1c 6-12%
Does not suffer from sever hypertension, kidney, liver or heart disease
Does not suffer from active Ischemic heart disease
Is willing to sign the consent form

Exclusion Criteria:

Participants age < 18 or > 65
Pregnancy
Breast feeding women
Un-controlled diabetes, HbA1c values > 12% range
Suffers from active Ischemic heart disease
Alcohol addiction
Is not prepared to signed the informed consent

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	Insuline Medical Ltd. ( gabriel bitton )
Study ID Numbers:	INS-0417-08-HMO
Study First Received:	October 4, 2008
Last Updated:	October 6, 2008
ClinicalTrials.gov Identifier:	NCT00767741
Health Authority:	Israel: Ministry of Health

Keywords provided by Insuline Medical Ltd.:

diabetes
post prandial glucose level
insulin
pharmacokinetics
pharmacodynamics

Study placed in the following topic categories:

Diabetes Mellitus
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009